510(k) K040913
K040913 is an FDA 510(k) premarket notification submitted by Bausch & Lomb for the device "NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)". The FDA issued a decision of Substantially Equivalent on July 23, 2004. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850. Bausch & Lomb has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2004
- Date Received
- April 8, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Device, Analysis, Anterior Segment
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type